Catalog Number

-

Brand Name

Wet Gel Monitoring Electrodes

Version/Model Number

V100300

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K030073,K030073,K030073

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

6121726d-1e33-412e-8317-5b9ccaa5fb5a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

00857175006159

Quantity per Package

200

Contains DI Package

10857175006132

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case of 1000